Asante Solutions, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0601-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Asante Conset Infusion Set with tubing & 9mm cannula packaged in 5-packs,singles,or inside a Combination Kit (FG-5249-4) Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark.

Product Classification:

Class II

Date Initiated: November 19, 2013

Date Posted: January 8, 2014

Recall Number: Z-0601-2014

Event ID: 66895

Reason for Recall:

Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.

Status: Terminated

Product Quantity: 1085 kits

Code Information:

Asante Catalog number:FG-4249-5, FG-4249T; Unomedical Item number: 43-110-5269; Lot numbers: 0230129 5005804 5040412.

Distribution Pattern:

Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated